In healthcare today, medical laboratories are key partners in ensuring and maintaining patient safety, and it is seen that laboratory results influence approx. 70% of medical decisions. Quality standards of the laboratory plays a major

In healthcare today, medical laboratories are key partners in ensuring and maintaining patient safety, and it is seen that laboratory results influence approx. 70% of medical decisions. Quality standards of the laboratory plays a major role in ensuring the correctness of these results, providing
better patient care as a whole and promoting excellence. While the absence of the same may lead to unreliable results, causing a delay in treatment, misdiagnosis and an increase in cost due to a need for retesting. COVID-19 Pandemic has affected everyone globally & correct lab diagnosis is very
important. Therefore, ICMR has made it mandatory to allow only accredited labs to perform RT-PCR test. Good quality is never brought about by accident; it is almost always the cumulative result of sincere intentions, dedicated effort, intelligent direction and skilful execution. As a choice, good quality may not necessarily be the easiest or the cheapest; however it is definitely the wisest for both patient
health and welfare as well as laboratory credibility. International standard ISO15189, based upon ISO17025 and ISO9001 standards, provides the basic requirements for establishing competence and serves as the bible for quality in medical laboratories. And while this serves as an excellent guiding principle, no matter how good the quality mechanisms are on paper, truly good quality cannot be achieved if theory is not translated into practice day-in and day-out. The entire process of managing a sample must be considered including the beginning i.e sample collection to end i.e reporting
and saving results.

Laboratory tests are influenced by :
*Lab environment
*Knowledgeable staff
*Reagents and Equipment
*Quality control

*Process management
*Occurrence management
*Record keeping
Following are the Quality essentials which act as building blocks for quality management.
Personnel: Human resources, job qualifications ,job descriptions, orientation, training, Competency
assessment, professional development, continuing education.

Equipment : Acquisition, installation, validation, maintenance, calibration , trouble shooting, service and repair, records.
Purchasing and inventory : Vendor qualification, supplies and reagents, critical services, contract review,

inventory management. Process control: Quality control, sample management, method validation,
method verification.

Information Management: Confidentiality, Requisitions, logs  and records, reports, computerised
laboratory information system(LIS) Documents : Creation, revision and
review, control and distribution. Records: Collection, review, storage ,
retention. Occurrence Management: Complaints, mistakes and problems,documentation,
root cause analysis, immediate actions, corrective actions and preventive actions.
Laboratory Assessment: Internal: Quality indicators, audit reports, audit reviews.
External: Proficiency testing, inspections, accreditation.
Process improvement: Opportunities for improvement (OFI), stakeholders feedback, problem resolution, risk assessment, preventive actions, corrective actions. Customer Service: Customer group
identification, customer needs, customer feedback.

Facilities and Safety: safe working environment, transport management, Security, Containment, waste

management, Laboratory safety,
Implementing an efficient Quality Management system does not guarantee a 100% error free laboratory, but it goes a long way in detecting errors that may occur commonly, and prevents them
from recurring. It essentially puts us on the path to continuous improvement, and brings us closer to our vision of bettering healthcare facilities every day. There is a cost associated with Quality,
but are we cognizant of the fact that poor quality costs us even more? Quality costs can be offset by quality payoffs like enhanced reputation, loyal clientele, reduced system failures & machine downtime, less need for retesting for complaints etc. However there is no offset for medical implications that may
be caused by poor quality, and its impact on not just the laboratories in question but on healthcare as a whole.

Thus, implementing and maintaining good quality standards in laboratories is no more a choice, as it is not just the ethical and moral duty of all laboratories to provide accurate, reliable results, but
it is essential to all aspects of healthcare and the medical profession.


Review overview